Rule 4729:5-7-03 | Persons eligible to transfer sample drugs to a charitable pharmacy.
(A) An eligible sample drug shall only be transferred directly to a charitable pharmacy by any of the following:
(1) A manufacturer licensed in accordance with section 4729.52 of the Revised Code, including a representative of the manufacturer;
(2) A person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer; or
(3) A prescriber practicing at a location that is licensed as a terminal distributor of dangerous drugs, unless exempt from licensure pursuant to section 4729.541 of the Revised Code.
(B) If a sample drug is transferred by a prescriber:
(1) A record must be created by the prescriber documenting the transfer. The record shall contain the:
(a) Name and address of the supplying prescriber;
(b) Name, strength, and quantity of the sample drug being transferred;
(c) Date of the sample drug transfer; and
(d) Name and address of the charitable pharmacy receiving the sample drug.
(2) A copy of all required records documenting the transfer of a sample drug shall be kept by the prescriber and the charitable pharmacy for a minimum of three years and shall be stored in a readily retrievable manner.
(3) The prescriber shall not transfer a sample drug to a charitable pharmacy unless the sample drug was received directly from a manufacturer, a manufacturer's representative, or by a person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer.
(4) The sample drug complies with the requirements of rule 4729:5-7-04 of the Administrative Code.
(5) The sample drug must not have any physical signs of tampering.
(6) The sample drug packaging must not have any physical signs of tampering.